Abstract
Biopharmaceutical drug substance and drug product release and stability testing, typically performed by Quality Control, is an essential part of the overall control strategy employed by a manufacturer to provide assurance of their product’s identity, purity, quality, potency, and safety. Each test method performed has an assigned limit or boundary, or descriptor, referred to as specification. In this chapter, the challenge of setting specifications for a biopharmaceutical, using a risk-based approach during clinical development and a formal justification when seeking market approval, will be examined.
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Geigert, J. (2019). The Art of Setting Specifications. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals . Springer, Cham. https://doi.org/10.1007/978-3-030-13754-0_13
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DOI: https://doi.org/10.1007/978-3-030-13754-0_13
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